Magnetic resonance imaging as a surrogate outcome for multiple sclerosis relapses
| Autor: | Ulrike Held, T. R. Fleming, Stephen C. Reingold, John Petkau, Jerry S. Wolinsky, Henry F. McFarland, M. D. Hughes, DH Miller, Gary Cutter |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
medicine.medical_specialty
Databases Factual Placebo-controlled study Gadolinium Disease Article Multiple Sclerosis Relapsing-Remitting Predictive Value of Tests Recurrence medicine Humans Clinical Trials as Topic medicine.diagnostic_test business.industry Surrogate endpoint Multiple sclerosis Magnetic resonance imaging medicine.disease Prognosis Magnetic Resonance Imaging Confidence interval Clinical trial Treatment Outcome Neurology Predictive value of tests Neurology (clinical) Radiology Nuclear medicine business Biomarkers |
| Zdroj: | Multiple sclerosis (Houndmills, Basingstoke, England). 14(6) |
| ISSN: | 1352-4585 |
| Popis: | Background Magnetic resonance imaging (MRI) of lesions in the brain may be the best current candidate for a surrogate biological marker of clinical outcomes in relapsing remitting multiple sclerosis (MS), based on its role as an objective indicator of disease pathology. No biological surrogate marker has yet been validated for MS clinical outcomes. Objective The objective of this study was to use a multi-phased study to determine if a valid surrogate relationship could be demonstrated between counts of contrast enhancing lesions (CELs) and occurrence of relapses in MS. Methods We examined correlations for the concurrent and predictive relationship between CELs over 6 months and MS relapses over the same 6 months and an additional 6 months (total: 12 months), using available data on untreated patients from a large clinical trial and natural history database. Results Concurrent and predictive correlations were inadequate to justify continuation of this study to the planned additional phases required to demonstrate a surrogate relationship between CELs and MS relapses. Conclusions Confidence intervals for correlations between CELs and MS relapses exclude the possibility that CELs can be a good surrogate for relapses over the time scales we investigated. Further exploration of surrogacy between MRI measures and MS clinical outcomes may require improved datasets, the development of MRI techniques that couple better to clinical disease, and the ability to test a wide range of imaging- and clinically-based hypotheses for surrogacy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|